FDA 发布 ICH Q8、Q9 和 Q10 问答文件（R5）正式版
FDA Final: Q8, Q9, and Q10 Questions and Answers (R5)
FDA 发布 ICH Q8、Q9 和 Q10 问答文件（R5）正式版，修订并更新 2011 年 11 月的 R4 版本。文件由 ICH 质量专家工作组制定，2024 年 10 月获 ICH 大会 Step 4 通过，内容涵盖设计空间、实时放行检测、控制策略、药品质量体系、知识管理及软件解决方案等问答。FDA 说明该指南为不具约束力的建议，除非引用了具体法规或法定要求。
文件以问答形式汇总ICH Q8、Q9与Q10实施中的具体问题，可帮助读者按设计空间、控制策略与知识管理等章节定位要点。
译文尚不完整，完整内容请切换到原文。
FDA 指南：Q8、Q9 和 Q10 问答（R5）
状态：正式。除非引用适用法律或法规，本指南包含非约束性建议。
FDA 目录发布日期：2026-05-29（源文件中为 MM/DD/YYYY）。
目录修改时间保留在源元数据中；它并非新的发布日期，也不能证明 PDF 已被修订。
产品：药品
主题：ICH-质量
发布办公室：药物评价与研究中心、生物制品评价与研究中心
文件类型：指南文件
官方详情页：https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q8-q9-and-q10-questions-and-answers-r5
范围：来自 FDA 全机构目录的公开指南 PDF，明确标记为药品/生物制品及生产/质量/ICH-质量。完整 PDF 如下。
PDF 文字版；图形和原始排版请参阅官方 PDF。
第 1 页
Q8、Q9 和 Q10
问答
(R5)
行业指南
美国卫生与公众服务部
食品药品监督管理局
药物评价与研究中心 (CDER)
生物制品评价与研究中心 (CBER)
2026 年 5 月
ICH-质量
第 2 页
Q8、Q9 和 Q10
问题与解答
(R5)
如需更多副本，可向以下机构索取：
药品信息部
药品评价与研究中心
美国食品药品监督管理局
电话：855-543-3784 或 301-796-3400
电子邮件：[email protected]
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs
和/或
沟通、外联与发展办公室
生物制品评价与研究中心
美国食品药品监督管理局
电话：800-835-4709 或 240-402-8010；电子邮件：[email protected]
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances
美国卫生与公众服务部
美国食品药品监督管理局
药品评价与研究中心（CDER）
生物制品评价与研究中心（CBER）
2026年5月
ICH-质量
第 3 页
包含非约束性建议
前言
人用药品技术要求国际协调理事会（ICH）的使命是在全球范围内实现更大程度的监管协调，以确保安全、有效和高质量的药品以最节约资源的方式开发、注册和维持。通过协调世界各地的监管期望，ICH 指南大幅减少了重复的临床研究，避免了不必要的动物试验，统一了安全性报告和上市申请提交，并为全球药物开发和生产的质量以及患者可获得的产品的诸多其他改进做出了贡献。
ICH 是一个以共识为驱动的过程，涉及来自监管机构和行业方的技术专家，开展详细的技术和科学协调工作，最终制定出 ICH 指南。全球监管机构对这些基于共识的指南的一致采纳承诺，对于为患者和行业实现安全、有效和高质量药品的益处至关重要。作为 ICH 的创始监管成员，美国食品药品监督管理局（FDA）在每一项 ICH 指南的制定中都发挥着重要作用，随后 FDA 将其采纳并作为对行业的指南发布。
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目录
（前言）............................................................................................................................................. 1
I. 引言 (1)..................................................................................................................... 2
A. 一般说明 (1.1) .............................................................................................. 2
II. 质量源于设计主题 (2) ........................................................................................... 3
A. 设计空间 (2.1) ................................................................................................................... 3
B. 实时放行检测 (RTRT) (2.2) .............................................................................. 5
C. 控制策略 (2.3) ............................................................................................................. 7
III. 药品质量体系 (3)......................................................................... 9
IV. ICH 质量指南对 GMP 检查实践的影响 (4) ........ 11
V. 知识管理 (5) ........................................................................................ 12
VI. 软件解决方案 (6) ................................................................................................... 14
参考文献 ..................................................................................................................................... 15
第 5 页
包含非约束性建议
Q8、Q9 和 Q10
问答（R5）
行业指南 1
本指南代表美国食品药品监督管理局（FDA 或本局）对该主题的当前思考。它不为任何人确立任何权利，
对 FDA 或公众均不具有约束力。如果替代方法满足适用法规和规章的要求，你可以采用替代方法。
如需讨论替代方法，请联系本指南标题页所列负责该指南的 FDA 办公室。
（前言）
本国际人用药品注册技术协调会（ICH）行业指南 Q8、Q9 和 Q10 问答（R5）（ICH Q8、
Q9 和 Q10（R5））针对与实施 ICH 行业指南 Q8(R2)《药品研发》（ICH Q8(R2)）（2009 年 11 月）、
Q9(R1)《质量风险管理》（ICH Q9(R1)）（2023 年 5 月）和 Q10《药品质量体系》（ICH Q10）（2009 年 4 月）相关的一些问题提供了答案。2 本指南修订并更新了 2011 年 11 月的
ICH 指南《Q8、Q9 和 Q10 问答（R4）》。
一般而言，FDA 的指南文件不确立法律上可强制执行的责任。相反，指南描述本局对某一主题的
当前思考，除非引用了具体的监管或法定要求，否则应仅视为建议。本局指南中使用“should”一词意味着某事是建议或推荐，但并非必需。
1
本指南由国际人用药品注册技术协调会（ICH）质量专家工作组制定，并已按照 ICH 流程
接受监管各方征求意见。本文件已由 ICH 大会在 ICH 流程第 4 阶段批准，2024 年 10 月。在流程第 4 阶段，最终草案被推荐供 ICH 各区域监管机构
通过。请将意见提交至案卷编号 FDA-2017-D-6821（可在
https://www.regulations.gov/docket?D=FDA-2017-D-6821 获取）。有关对本指南及其他第 2 级指南提交意见的说明，请参见该案卷。
2
我们会定期更新指南。为确保你拥有指南的最新版本，请查看 FDA 指南网页
https://www.fda.gov/regulatory-information/search-fda-guidance-documents。
1
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I. 引言 (1) 3
A. 一般澄清 (1.1)
表 1. ICH Q8、Q9 和 Q10 (R5) 第 I 节 (1) 的问答
批准日期 问题 回答
2009 年 6 月 1 监管机构是否接受最低限度方法？是的。ICH Q8(R2) 中定义的最低限度方法（有时也称为
‘基线’或‘传统’方法）是完全可接受申报所应达到的预期。
然而，鼓励采用 ICH Q8(R2) 中所述的‘增强’方法
（参见 ICH Q8(R2) 附录 1）。
2009 年 10 月 2 使用 ICH Q8、Q9 和 Q10 进行工艺 使用 ICH Q8、Q9 和 Q10 时，工艺验证的目标不变。
验证的适当方法是什么？ 工艺验证的主要目标仍然是：工艺设计能够生产出符合其
预定质量标准的产品。ICH Q8、Q9 和 Q10 提供了一种结构化方法，用于定义产品关键质量属性、
设计空间、生产工艺和控制策略。这些信息可用于确定在
初始商业生产批次之前以及在其上所要进行的研究类型和重点。作为
传统工艺验证的替代方法，连续工艺确认（参见 ICH Q8(R2) 术语表中的定义）可用于
初始商业生产的工艺验证方案，以及产品生命周期剩余阶段
为持续改进而进行的生产工艺变更。
2024 年 10 月 3 在 ICH Q8、Q9 和 Q10 下，质量风险 与产品本身一样，工艺验证也具有生命周期（工艺设计、
管理的信息和连续工艺确认如何 工艺确认和持续工艺确认）。在初始商业验证批次之前
为稳健的持续改进方法提供支持？ 进行的风险评估可以突出显示需要特别关注和数据的
领域，以证明商业工艺稳健性具有高水平的保证。持续监测（例如，
通过连续工艺确认）可以进一步证明工艺一致性的实际保证水平，
并为产品的持续改进提供依据。ICH Q9(R1) 的质量风险管理
方法可应用于整个产品生命周期，以维持工艺控制状态。
3
括号中的数字反映了 ICH 大会于 2024 年 10 月 ICH 进程第 4 步批准的文件组织结构。
2
第 7 页
包含非约束性建议
II. 质量源于设计主题 (2)
表 2. ICH Q8、Q9 和 Q10 (R5) 第 II 节 (2) 的问答
批准日期 问题 回答
1 2024年10月 实施 QbD 是否总是需要设计空间 (DS) 或实时放行检测 (RTRT)？ 在质量源于设计下，建立设计空间或使用 RTRT 并非必然预期（参见 ICH Q8(R2)）。
A. 设计空间 (2.1)
1 2009年4月 是否有必要研究所有参数的多变量交互作用以开发设计空间？ 不，申请人需要基于风险评估和期望的操作灵活性，论证多变量实验所选择的物料属性和参数。
2 2024年10月 设计空间是否可适用于放大？ 是，在适当论证的情况下可以（更多细节参见 ICH Q8(R2) 第 II.D.4 (2.4.4) 节，“设计空间与规模和设备的关系”）。
3 2024年10月 设计空间是否可适用于场地变更？ 是，可以基于对工艺稳健性的已证明理解以及对场地特定因素（例如物料、设备、人员、公用设施、生产环境和设备）的深入考虑，使用场地独立的设计空间来论证场地变更。场地变更需遵循各区域特定的监管要求。
4 2009年4月 设计空间可否针对单一和/或多个单元操作开发？ 是，可以针对单一单元操作或一系列单元操作开发设计空间（参见 ICH Q8(R2) 第 II.D.3 (2.4.3) 节，“单元操作设计空间”）。
5 2024年10月 是否可以为现有产品开发设计空间？ 是，可以。生产数据和工艺知识可用于支持现有产品的设计空间。应利用来自例如商业规模生产、原材料、工艺改进、CAPA、开发数据以及风险审查相关知识的有关信息。
对于在固定设备中于狭窄操作范围内运行的生产操作，扩展的操作区域以及对多参数
3
第 8 页
包含非约束性建议
仅凭现有生产数据可能无法实现相互作用，并且
可能需要额外研究以建立设计空间。应证明具备充分的知识，
并应通过实验支持设计空间，以
研究相互作用并确定参数/属性范围。
6 2009年4月 对于现有产品，是否有建立设计空间的监管期望？ 否，除非申请人有特定需求并希望利用设计空间来实现更高
程度的产品和工艺理解，否则无需为现有产品建立设计空间。这可能会增加生产
灵活性和/或稳健性。
7 2009年6月 设计空间是否可适用于处方？ 是，可能可以建立处方（不是组分而是组成）
设计空间，由辅料用量及其理化
性质（例如粒径分布、聚合物取代度）的范围组成，基于对
更广泛物料属性的增强知识。申请人应
针对质量属性（如生物等效性、稳定性、生产稳健性等）
论证建立设计空间的依据。根据物料属性在设计空间内进行处方
调整，无需在监管上市后变更中提交。
8 2009年6月 一组已验证可接受范围本身是否构成设计空间？ 否，由单变量实验开发的一组已验证可接受范围（PARs）
不构成设计空间（见ICH Q8(R2)第II.D.5节
（2.4.5）“设计空间与已验证可接受范围”）。仅来自单变量实验的已验证可接受范围
可能缺乏对工艺参数和/或物料属性之间相互作用的
理解。然而，从监管角度看，已验证可接受
范围仍可接受，但不被视为
设计空间（见ICH Q8(R2)第II.D.5节（2.4.5）“设计空间与已验证
可接受范围”）。申请人可选择对生产工艺的不同方面使用已验证可接受范围或
设计空间。
9 2024年10月 在工艺验证研究中，是否应在商业规模下评估设计空间的外边界？ 否，无需在商业规模工艺验证研究中在设计空间的外边界运行
工艺确认批次。设计空间
必须在早期开发研究中进行充分探索（关于放大，另见
第3页第II.A节（2.1）“设计空间问题2”；关于生命周期方法见第
2页第A节（1.1）“关于问题3的一般澄清”）。
4
第 9 页
Contains Nonbinding Recommendations
B. Real Time Release Testing (RTRT) (2.2)
Date of Questions Answers
Approval
1 Oct. How is batch release affected by employing Batch release is the final decision to release the product to the market regardless of
2024 RTRT? whether RTRT or end product testing is employed. End product testing involves
performance of specific analytical procedures on a defined sample size of the final
product after completion of all processing for a given batch of that product. Results of
RTRT are handled in the same manner as end product testing results in the batch release
decision. Batch release involves an independent review of batch conformance to
predefined criteria through the review of testing results and manufacturing records,
together with an effective quality system that ensures GM P compliance, regardless of
which approach is used.
2 Apr. Does RTRT mean elimination of end product RTRT does not necessarily eliminate all end product testing. For example, an applicant
2009 testing? may propose RTRT for some attributes only or not all. If all CQAs (relevant for
RTRT) are assured by in-process monitoring of parameters and/or testing of materials,
then end product testing might not be needed for batch release. Some product testing
will be expected for certain regulatory processes such as stability studies or regional
requirements.
3 Apr. Is a product specification still necessary in the Yes, product specifications (see the ICH guidelines Q6A Specifications: Test
2009 case of RTRT? Procedures and Acceptance Criteria for New Drug Substances and New Drug
Products: Chemical Substances (finalized October 6, 1999) and Q6B Specifications:
Test Procedures and Acceptance Criteria for Biotechnological/Biological Products)
(finalized March 10, 1999) still need to be established and met, when tested.
4 Oct. When using RTRT, is there a need for stability Even where RTRT is applied, a stability monitoring protocol that uses stability-
2024 test methods? indicating methods is required for all products regardless of the means of release testing
(see the ICH guidances for industry Q1A(R2) Stability Testing of New Drug Substances
and Products (November 2003) and Q5C Quality of Biotechnological Products:
Stability Testing of Biotechnological/Biological Products (July 1996)).
5
第 10 页
Contains Nonbinding Recommendations
Date of Questions Answers
Approval
5 Oct. What is the relationship between Control Strategy RTRT, if utilized, is an element of the Control Strategy and may enable appropriate in-
2024 and RTRT? process testing (in-line, on-line, at-line) of quality attributes rather than testing on the
end product. This use of RTRT recognizes that under specific circumstances an
appropriate combination of process controls (critical process parameters) together with
pre-defined material attributes may provide greater assurance of product quality than
end product testing and as such be an integral part of the control strategy.
6 Oct. Do traditional sampling approaches apply to No, traditionally sampling plans for in-process and end-product testing involve a
2024 RTRT? discrete sample size that represents the minimal sampling expectations. Generally, the
use of RTRT will include more extensive on-line/in-line measurements. A
scientifically sound sampling approach should be developed, justified, and
implemented.
7 Oct. If RTRT results fail or trending toward failure, No, in principle the RTRT results should be routinely used for the batch release
2024 can end-product testing be used to release the decisions and not be substituted by end-product testing. Any failure should be
batch? investigated, and trending should be followed up appropriately. However, batch release
decisions will need to be made based on the results of the investigations. The batch
release decision needs to comply with the content of the marketing authorization and
GMP compliance.
8 Oct. What is the relationship between in-process In-process testing includes any testing that occurs during the manufacturing process of
2024 testing and RTRT? drug substance and/or finished product. RTRT includes those in-process tests that
directly impact the decision for batch release through evaluation of Critical Quality
Attributes.
9 Jun. What is the difference between ‘real time release’ The definition of RTRT in ICH Q8(R2) is “the ability to evaluate and ensure the
2009 and ‘RTRT’? acceptable quality of in- process and/or final product based on process data, which
typically includes a valid combination of measured material attributes and process
controls.” The term ‘Real time release’ in the ICH Q8(R2), Step 2 document was
revised to RTRT in the final ICH Q8(R2) Part II document to fit the definition more
accurately and thus avoid confusion with batch release.
10 Oct. Can a surrogate measurement be used for RTRT? Yes, RTRT can be based on measurement of surrogate (e.g., process parameter,
2024 material attribute) that has been demonstrated to correlate with an in-process or end-
product specification (see ICH Q8(R2); Section II.E (2.5)).
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Contains Nonbinding Recommendations
Date of Questions Answers
Approval
11 Oct. What is the relationship between RTRT and Parametric release is one type of RTRT. Parametric release is based on process data
2024 Parametric Release? (e.g., temperature, pressure, time for terminal sterilization, physicochemical indicator)
rather than the testing of material and/or a sample for a specific attribute.
C. Control Strategy (2.3)
Refer to the definition of control strategy provided in the ICH Q10 glossary definition:
A planned set of controls, derived from current product and process understanding that assures process performance and product quality.
The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and
equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of
monitoring and control.
Date of Questions Answers
Approval
1 Apr. What is the difference in a control strategy for Control strategies are expected irrespective of the development approach. Control
2009 products developed using the minimal approach strategy includes different types of control proposed by the applicant to assure
versus ‘quality-by-design’ approach? product quality (see ICH Q10, Section III.B.1 (3.2.1), “Process Performance and
Product Quality Monitoring System”), such as in-process testing and end-product
testing. For products developed following the minimal approach, the control strategy
is usually derived empirically and typically relies more on discrete sampling and end
product testing. Under QbD, the control strategy is derived using a systematic
science and risk-based approach. Testing, monitoring, or controlling is often shifted
earlier into the process and conducted in-line, on-line or at-line testing.
2 Apr. Are GMP requirements different for batch release No, the same GMP requirements apply for batch release under minimal and QbD
2009 under QbD? approaches.
3 Apr. What is the relationship between a Design Space A control strategy is required for all products. If a Design Space is developed and
2009 and a Control Strategy? approved, the Control Strategy (see ICH Q8(R2), Section II.D (2.4), “Design Space”)
provides the mechanism to ensure that the manufacturing process is maintained
within the boundaries described by the Design Space.
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Date of Questions Answers
Approval
4 Jun. What approaches can be taken in the event of on- The control strategy provided in the application should include a proposal for use of
2009 line/in- line/at-line testing or monitoring alternative testing or monitoring approaches in cases of equipment failure. The
equipment breakdown? alternative approach could involve use of end product testing or other options, while
maintaining an acceptable level of quality. Testing or monitoring equipment
breakdown needs to be managed in the context of a deviation under the Quality
System and can be covered by GMP inspection.
5 Oct. Are product specifications different for minimal In principle, no, the same product specifications are needed for minimal and QbD
2009 versus QbD approaches? approaches. For a QbD approach, the control strategy may allow achieving the end
product specifications via RTRT approaches (see ICH Q8(R2), Appendix 1).
Product must meet specifications when tested.
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III. PHARMACEUTICAL QUALITY SYSTEM (3)
Table 3. Q&A for Section III (3) of ICH Q8, Q9, and Q10 (R5)
Date of Questions Answers
Approval
1 Oct. What are the benefits of implementing a The benefits are:
2024 Pharmaceutical Quality System (in accordance
• A robust manufacturing process, through facilitation of continual improvement
with ICH Q10)?
through science and risk-based post approval change processes;
• Consistency in the global pharmaceutical environment across regions;
• Transparency of systems, processes, organizational and management
responsibility within, and across, companies (e.g., contract organizations);
• Clearer understanding of the application of the Pharmaceutical Quality System
throughout product lifecycle;
• Further reduced risk of product failure and incidence of complaints and recalls,
thereby providing greater assurance of pharmaceutical product consistency and
availability (supply) to the patient;
• Better process performance, supported by effective risk reviews;
• Opportunities to increase understanding between industry and regulators and
more optimal use of industry and regulatory resources. Enhanced manufacturers
and regulators’ confidence in product quality;
• Greater assurance of compliance with GMP, which builds confidence in the
regulators, and which may result in shorter inspections.
• Knowledge-driven and objective risk assessments which help achieve science-and
risk-based control strategies, and which lead to effective risk-based decisions as
well as reduced product availability risks relating to quality/manufacturing issues.
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Date of Questions Answers
Approval
2 Apr. How does a company demonstrate implementation When implemented, a company will demonstrate the use of an effective PQS through
2009 of PQS in accordance with ICH Q10? its documentation (e.g., policies, standards), its processes, its training/qualification, its
management, its continual improvement efforts, and its performance against pre-
defined Key Performance Indicators (see ICH Q10 glossary on ‘Performance
indicator’). A mechanism should be established to demonstrate at a site how the PQS
operates across the product lifecycle, in an easily understandable way for
management, staff and regulatory inspectors, e.g., a quality manual, documentation,
flowcharts, procedures. Companies can implement a program in which the PQS is
routinely audited in-house (i.e., internal audit program) to ensure that the system is
functioning at a high level.
3 Oct. Is it necessary to describe the PQS in a regulatory No, however relevant elements of the PQS, such as quality monitoring system,
2024 submission? change management, and deviation management may be referenced as part of the
control strategy as supporting information.
4 Oct. Is there certification that the PQS is in accordance No. There is no specific ICH Q10 certification program.
2024 with ICH Q10?
5 Apr. How should the implementation of the design Inspection should verify/assess that manufacturing operations are appropriately
2009 space be evaluated during inspection of the carried out within the Design Space. The inspector in collaboration with the assessor,
manufacturing site? where appropriate, should also verify successful manufacturing operations under the
Design Space and that movement within the Design Space is managed within the
company’s change system (see ICH Q10, Section III.B (3.2), Table III).
6 Apr. What should be done if manufacturing operations This should be handled as a deviation under GMP. For example, unplanned ‘one-off’
2009 run inadvertently outside of the Design Space? excursions occurring as a result of unexpected events, such as operator error or
equipment failure, would be investigated, documented, and dealt with as a deviation
in the usual way. The results of the investigation may contribute to the process of
knowledge, preventive actions, and continual improvement of the product.
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Date of Questions Answers
Approval
7 Oct. What information and documentation of the Pharmaceutical development information (e.g., supporting information on design
2024 development studies should be available at a space, chemometric model, outputs of quality risk management activities) is available
manufacturing site? at the development site. Pharmaceutical development information which is useful to
ensure the understanding of the basis for the manufacturing process and control
strategy, including the rationale for selection of critical process parameters and
critical quality attributes should be available at the manufacturing site.
Scientific collaboration and knowledge sharing between pharmaceutical development
and manufacturing are essential to ensure the successful transfer to production.
8 Jun. Can process parameters be adjusted throughout Process parameters are studied and selected during pharmaceutical development and
2009 the product lifecycle? monitored during commercial manufacturing. Knowledge gained could be utilized
for adjustment of the parameters as part of continual improvement of the process
throughout the lifecycle of the drug product (see ICH Q10, Section III (3),
“Management Responsibility”).
IV. ICH QUALITY GUIDELINES’ IMPACT ON GMP INSPECTION PRACTICES (4)
Table 4. Q&A for Section IV (4) of ICH Q8, Q9, and Q10 (R5)
Date of Questions Answers
Approval
1 Oct. How do product-related inspections differ in an In the case of product-related inspection (in particular pre-authorization) depending
2024 ICH Q8, Q9, and Q10 environment? on the complexity of the product and/or process, there may be a need for greater
collaboration between inspectors and assessors, for example, for the assessment of
development data. The inspection would normally occur at the proposed commercial
manufacturing site and there may be greater focus on enhanced process understanding
and understanding relationships, e.g., Critical Quality Attribute (CQAs), Critical
Process Parameters (CPPs). It may also extend into the application and
implementation of quality risk management principles, as supported by the
Pharmaceutical Quality System (PQS).
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Date of Questions Answers
Approval
2 Oct. How do system-related inspections differ in an Such inspections have greater focus (but not only) on how the PQS facilitates the use
2024 ICH Q8, Q9 and Q10 environment? of e.g., Quality Risk Management methods, implementation of design space and
change management (see ICH Q10).
3 Oct. How is control strategy approved in the Elements of the control strategy submitted in the application are reviewed and
2024 application and evaluated during inspection? approved by the regulatory agency. However, additional elements are subject to
inspection (as described in ICH Q10).
V. KNOWLEDGE MANAGEMENT (5)
Table 5. Q&A for Section V (5) of ICH Q8, Q9, and Q10 (R5)
Date of Questions Answers
Approval
1 Oct. How has the implementation of ICH Q8, Q9, and ICH Q10 defines knowledge management as “systematic approach to acquiring,
2024 Q10 changed the significance and use of knowledge analyzing, storing, and disseminating information related to products,
management? manufacturing processes and components.” Knowledge Management is not a new
concept. It is always important regardless of the development approach. ICH Q10
highlights knowledge management because it is expected that more complex
information generated by appropriate approaches (e.g., QbD, PAT, real-time data
generation, and control monitoring systems) need to be captured, managed and
shared during product life cycle. In conjunction with Quality Risk Management,
Knowledge Management can facilitate the use of concepts such as prior knowledge
(including from other similar products), development of design space, control
strategy, technology transfer, and continual improvement across the product life
cycle.
2 April Does ICH Q10 suggest an ideal way to manage No. ICH Q10 provides a framework and does not prescribe how to implement
2009 knowledge? knowledge management. Each company decides how to manage knowledge,
including the depth and extent of information assessment based on their specific
needs.
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Date of Questions Answers
Approval
3 Oct. What are examples of sources of information for Some examples of knowledge sources are:
202 Knowledge Management? • Prior knowledge based on experience obtained from similar processes (internal
knowledge, industry, scientific and technical publications) and published
information (external knowledge: literature and peer-reviewed publications);
• Pharmaceutical development studies;
• Mechanism of action;
• Structure/function relationships;
• Technology transfer activities;
• Process validation studies;
• Manufacturing experience e.g.:
- Internal and vendor audits;
- Raw material testing data;
• Innovation;
• Continual improvement;
• Change management activities;
• Stability reports;
• Product Quality Reviews/Annual Product Reviews;
• Complaint Reports;
• Adverse event reports (Patient safety);
• Deviation Reports, Recall Information;
• Technical investigations and/or CAPA reports;
• Suppliers and Contractors;
• Product history and /or manufacturing history;
• Ongoing manufacturing processes information (e.g., trends);
• Risk assessments and other quality risk management activities.
Information from the above can be sourced and shared across a site or company,
between companies and suppliers/contractors, products and across different
disciplines (e.g., development, manufacturing, engineering, quality units).
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Date of Questions Answers
Approval
4 Apr. Is a specific dedicated computerized information No, but such computerized information management systems can be invaluable in
2009 management system required for the capturing, managing, assessing, and sharing complex data and information.
implementation of knowledge management with
respect to ICH Q8, Q9 and Q10?
5 Oct. Do regulatory agencies expect to see a formal No. There is no regulatory requirement for a formal knowledge management
2024 knowledge management approach during system. However, it is expected that knowledge from different processes and
inspections? systems is appropriately utilized.
Note: ‘formal’ in this context means a structured approach using a recognized
methodology or (IT-) tool, executing and documenting something in a transparent
and detailed manner.
VI. SOFTWARE SOLUTIONS (6)
Table 6. Q&A for Section VI (6) of ICH Q8, Q9, and Q10 (R5)
Date of Questions Answers
Approval
1 Oct. Is it necessary for a pharmaceutical firm to purchase No. ICH has not endorsed any commercial products and does not intend to do so.
2024 products that are marketed as ‘ICH compliant ICH is not a regulatory agency with reviewing authority and thus does not have a
solutions’ or ICH Q8, Q9, and Q10 Implementation role in determining or defining ‘ICH compliance’ for any commercial products. If
software, etc.to achieve a successful considering such products, firms will need to carry out their own evaluation of these
implementation of these ICH guidances within their products relative to their business needs. Computer system validation studies
companies? should be performed by companies to evaluate the reliability of potential software.
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REFERENCES
The following references are available on the Search for FDA Guidance Documents web page
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. We update
guidances periodically. To make sure you have the most recent version of a guidance, check
the FDA Drugs guidance web page.
ICH Q8(R2) Pharmaceutical Development (November 2009)
Part I: Pharmaceutical Development’
Part II: Pharmaceutical Development (Annex)
ICH Q9(R1) Quality Risk Management (May 2023)
ICH Q10 Pharmaceutical Quality Systems (April 2009)
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来源：FDA 全域目录：药品／生物制品制造质量指南 · fda.gov